Greater China Metabolic and Bariatric Surgery Database

• Sponsor: Beijing Friendship Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03800160
• Collaborator: Beijing Tiantan Hospital (Other), Beijing Shijitan Hospital, Capital Medical University (Other), Beijing Hospital (Other), Peking Union Medical College Hospital (Other), Shanxi Dayi Hospital (Other), The Second Hospital of Hebei Medical University (Other), Tianjin Medical University General Hospital (Other), Inner Mongolia People's Hospital (Other), Henan Provincial People's Hospital (Other), Qilu Hospital of Shandong University (Other), The First Hospital of Hebei Medical University (Other), The Second People's Hospital of Xinxiang Henan (Other), Tangshan Gongren Hospital (Other), Tianjin Nankai Hospital (Other), Tianjin First Central Hospital (Other)
• Enrollment: 5,000
• Location: 1
• Anticipated Duration (Months): 132
• Patients Per Site Per Month: 37.9

Study Details

Study Description

Brief Summary

Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Surgery

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 5000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Greater China Metabolic and Bariatric Surgery Database
• Actual Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Apr 1, 2028
• Anticipated Study Completion Date: Apr 1, 2029

Outcome Measures

Primary Outcome Measures

1. the excess weight loss effect of different metabolic surgeries after 1year [1 year after surgery]

   Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)

Secondary Outcome Measures

1. the adverse events rate of different metabolic surgeries [30 days after surgery]

   show the surgical safety by 30 days follow-up according to guideline（such as: bleeding, leak, obstruction, re-operation for complication）

2. the excess weight loss effect of metabolic surgery with long-time follow-ups [3 years]

   Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)

3. the excess weight loss effect of metabolic surgery with long-time follow-ups [5 years]

   Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)

4. the excess weight loss effect of metabolic surgery with long-time follow-ups [10 years]

   Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)

5. the glycemic control level of metabolic surgery with long-time follow-ups [1 year after surgery]

   the change of HbA1c, glucose level, C-peptide and insulin levels

6. the glycemic control level of metabolic surgery with long-time follow-ups [3 year after surgery]

   the change of HbA1c, glucose level, C-peptide and insulin levels

7. the glycemic control level of metabolic surgery with long-time follow-ups [5 year after surgery]

   the change of HbA1c, glucose level, C-peptide and insulin levels

8. the glycemic control level of metabolic surgery with long-time follow-ups [10 year after surgery]

   the change of HbA1c, glucose level, C-peptide and insulin levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• be able to receive metabolic surgery, including but not limit to LSG and LRYGB

Exclusion Criteria:

• can not be able to understand and willing to participate in this registry with signature

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital	Beijing	Beijing	China	100050

Sponsors and Collaborators

• Beijing Friendship Hospital
• Beijing Tiantan Hospital
• Beijing Shijitan Hospital, Capital Medical University
• Beijing Hospital
• Peking Union Medical College Hospital
• Shanxi Dayi Hospital
• The Second Hospital of Hebei Medical University
• Tianjin Medical University General Hospital
• Inner Mongolia People's Hospital
• Henan Provincial People's Hospital
• Qilu Hospital of Shandong University
• The First Hospital of Hebei Medical University
• The Second People's Hospital of Xinxiang Henan
• Tangshan Gongren Hospital
• Tianjin Nankai Hospital
• Tianjin First Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhongtao Zhang, Director of general surgery, principal investigator, Beijing Friendship Hospital
• ClinicalTrials.gov Identifier: NCT03800160
• Other Study ID Numbers: GC-MBD
• First Posted: Jan 11, 2019
• Last Update Posted: May 5, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhongtao Zhang, Director of general surgery, principal investigator, Beijing Friendship Hospital: metabolic surgery; metabolic disease; multicenter

Study Results

No Results Posted as of May 5, 2020